Vanda Pharmaceuticals Receives Orphan Drug Designation in Japan
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Vanda Pharmaceuticals announced that Japan's Ministry of Health, Labour and Welfare has granted orphan drug designation to imsidolimab, a high-affinity humanized immunoglobulin G4 monoclonal antibody, for the treatment of generalized pustular psoriasis. The MHLW grants orphan drug designation to medicines intended to treat rare diseases with significant unmet medical need. In Japan, approximately 2,200 people have been diagnosed with GPP. In Japan, orphan drug designation provides development incentives, including subsidies for research and development costs, as well as the potential for up to 10 years of market exclusivity following approval. This designation follows similar regulatory recognition in the U.S.
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Analyst Views on VNDA
Wall Street analysts forecast VNDA stock price to rise
4 Analyst Rating
3 Buy
1 Hold
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Strong Buy
Current: 6.640
Low
7.50
Averages
13.63
High
22.00
Current: 6.640
Low
7.50
Averages
13.63
High
22.00
About VNDA
Vanda Pharmaceuticals Inc. is a global biopharmaceutical company, which is focused on the development and commercialization of therapies to address unmet medical needs and improve the lives of patients. The Company's commercial portfolio consist of four products: Fanapt for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia, HETLIOZ for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) and for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome, PONVORY for the treatment of relapsing forms of multiple sclerosis (RMS) including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease , and NEREUS for the prevention of vomiting induced by motion. In addition, it has a number of drugs and/or additional indications for current products in development, including Bysanti, Imsidolimab, VTR-297, VQW-765, and others. Bysanti is the active metabolite of Fanapt.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Vanda Pharmaceuticals Receives Orphan Drug Designation in Japan
- Orphan Drug Designation: Vanda Pharmaceuticals announced that its drug Imsidolimab has received orphan drug designation from Japan's Ministry of Health, Labour and Welfare, aimed at treating generalized pustular psoriasis, a rare autoinflammatory disease that can lead to severe complications if untreated.
- Patient Impact: Approximately 2,200 individuals in Japan are affected by generalized pustular psoriasis, and Imsidolimab is designed to inhibit interleukin-36 (IL-36) receptor signaling, addressing the deficiency of the endogenous IL-36 receptor antagonist observed in patients, thereby improving their quality of life.
- Market Exclusivity: With orphan drug designation, Vanda will benefit from up to 10 years of market exclusivity and subsidies for research and development costs, significantly lowering its barriers to entry in the Japanese market and enhancing its profit potential.
- Stock Market Reaction: Vanda's stock closed up 3.86% at $6.46 on Wednesday, with after-hours trading showing a further increase of 1.24% to $6.54, reflecting positive market expectations regarding the drug's prospects.
See More
Vanda Pharmaceuticals to Participate in Upcoming Investor Conferences
- Investor Conference Schedule: Vanda Pharmaceuticals will participate in three significant investor conferences in May 2026, including the Bank of America Securities Global Health Care Conference on May 12 in Las Vegas, showcasing its latest advancements in the biopharmaceutical sector to attract more investor interest.
- Conference Details: At the HCW 4th Annual BioConnect Investor Conference on May 19, Vanda will hold a fireside chat at 2:00 p.m. Eastern Time, expected to discuss the company's strategic direction and future development plans, thereby enhancing investor confidence.
- Live Streaming Access: Investors can access the fireside chat live on Vanda's corporate website during the HCW conference, emphasizing the company's commitment to transparency and investor relations by advising attendees to register and download necessary software 15 minutes prior to the event.
- Long-term Development Vision: Vanda Pharmaceuticals focuses on developing innovative therapies to address unmet medical needs, and participating in these conferences not only helps raise the company's profile but also lays the groundwork for its future commercialization strategy, driving sustained growth in the biopharmaceutical industry.
See More
Vanda Pharmaceuticals Q1 2026 Earnings Call Highlights
- Significant Sales Growth: Vanda Pharmaceuticals reported a 26% year-over-year increase in Fanapt sales during Q1 2026, indicating strong market execution, although total revenues of $51.7 million declined from $57.2 million in Q4 2025, primarily due to insurance plan disruptions.
- New Product Launch: The U.S. launch of NEREUS was successful, utilizing an innovative direct-to-consumer platform, with projected revenues of $10 million to $30 million for 2026, although management acknowledged that this range is not yet informed by actual data.
- FDA Approval of New Drug: BYSANTI received FDA approval for the treatment of bipolar I disorder and schizophrenia, with data exclusivity lasting until February 2031, which is expected to provide robust support for future revenue growth.
- Adjusted Financial Outlook: Vanda raised its full-year 2026 revenue guidance to $240 million to $290 million, reflecting the potential contribution from NEREUS while maintaining expectations for Fanapt and other products, demonstrating confidence in future growth prospects.
See More
Vanda Pharmaceuticals Q1 2026 Earnings Report
- Disappointing Earnings: Vanda Pharmaceuticals reported a Q1 2026 GAAP EPS of -$0.82, missing expectations by $0.13, indicating challenges in profitability that could undermine investor confidence.
- Slight Revenue Growth: The company achieved revenue of $51.7 million in Q1, a 3.3% year-over-year increase, yet fell short of expectations by $1.2 million, suggesting pressure in market competition and the need for enhanced sales strategies.
- Deteriorating Cash Position: As of March 31, 2026, Vanda's cash and cash equivalents totaled $202.3 million, a decrease of $61.5 million in Q1, which included a one-time $10 million milestone payment to Eli Lilly, reflecting tight cash management.
- Upgraded 2026 Financial Guidance: Vanda raised its total revenue guidance for 2026 to $240 million to $290 million, reflecting contributions from the newly launched NEREUS™ product, while maintaining previous guidance for Fanapt® and other products, demonstrating confidence in the new product's market potential.
See More
Vanda Pharmaceuticals Launches Nereus™ (Tradipitant), the First New Medication for Motion Sickness in Over 40 Years, Now Available in the U.S.
Announcement of New Treatment: Vanda Pharmaceuticals has announced the U.S. commercial availability of Nereus™ (tradipitant), the first new pharmacologic treatment for people suffering from motion sickness in over 40 years.
Significance of the Treatment: This new treatment aims to provide relief for individuals who experience motion sickness, addressing a long-standing need in the pharmaceutical market.
See More
Vanda Pharmaceuticals Launches NEREUS, First New Motion Sickness Drug in 40 Years
- New Drug Launch: Vanda Pharmaceuticals has announced the U.S. commercial launch of NEREUS, marking the first new prescription medicine for motion sickness in over 40 years, expected to meet the needs of approximately 65 to 78 million Americans and significantly improve patient travel experiences.
- Successful Clinical Trials: NEREUS received FDA approval on December 30, 2025, after two pivotal Phase 3 trials demonstrated significant vomiting prevention, enhancing the drug's competitive position in the market.
- Convenient Dosing Regimen: Patients can take one or two capsules about an hour before travel, simplifying the medication process, which is likely to attract more patients and drive sales growth.
- Price Advantage: With a cash-pay price of $85 per dose compared to the standard price of $255, NEREUS offers a significant cost advantage, expected to enhance patient acceptance and market penetration.
See More
Vanda Pharmaceuticals Receives Orphan Drug Designation in Japan
- Orphan Drug Designation: Vanda Pharmaceuticals announced that its drug Imsidolimab has received orphan drug designation from Japan's Ministry of Health, Labour and Welfare, aimed at treating generalized pustular psoriasis, a rare autoinflammatory disease that can lead to severe complications if untreated.
- Patient Impact: Approximately 2,200 individuals in Japan are affected by generalized pustular psoriasis, and Imsidolimab is designed to inhibit interleukin-36 (IL-36) receptor signaling, addressing the deficiency of the endogenous IL-36 receptor antagonist observed in patients, thereby improving their quality of life.
- Market Exclusivity: With orphan drug designation, Vanda will benefit from up to 10 years of market exclusivity and subsidies for research and development costs, significantly lowering its barriers to entry in the Japanese market and enhancing its profit potential.
- Stock Market Reaction: Vanda's stock closed up 3.86% at $6.46 on Wednesday, with after-hours trading showing a further increase of 1.24% to $6.54, reflecting positive market expectations regarding the drug's prospects.
See More
Vanda Pharmaceuticals to Participate in Upcoming Investor Conferences
- Investor Conference Schedule: Vanda Pharmaceuticals will participate in three significant investor conferences in May 2026, including the Bank of America Securities Global Health Care Conference on May 12 in Las Vegas, showcasing its latest advancements in the biopharmaceutical sector to attract more investor interest.
- Conference Details: At the HCW 4th Annual BioConnect Investor Conference on May 19, Vanda will hold a fireside chat at 2:00 p.m. Eastern Time, expected to discuss the company's strategic direction and future development plans, thereby enhancing investor confidence.
- Live Streaming Access: Investors can access the fireside chat live on Vanda's corporate website during the HCW conference, emphasizing the company's commitment to transparency and investor relations by advising attendees to register and download necessary software 15 minutes prior to the event.
- Long-term Development Vision: Vanda Pharmaceuticals focuses on developing innovative therapies to address unmet medical needs, and participating in these conferences not only helps raise the company's profile but also lays the groundwork for its future commercialization strategy, driving sustained growth in the biopharmaceutical industry.
See More
Vanda Pharmaceuticals Q1 2026 Earnings Call Highlights
- Significant Sales Growth: Vanda Pharmaceuticals reported a 26% year-over-year increase in Fanapt sales during Q1 2026, indicating strong market execution, although total revenues of $51.7 million declined from $57.2 million in Q4 2025, primarily due to insurance plan disruptions.
- New Product Launch: The U.S. launch of NEREUS was successful, utilizing an innovative direct-to-consumer platform, with projected revenues of $10 million to $30 million for 2026, although management acknowledged that this range is not yet informed by actual data.
- FDA Approval of New Drug: BYSANTI received FDA approval for the treatment of bipolar I disorder and schizophrenia, with data exclusivity lasting until February 2031, which is expected to provide robust support for future revenue growth.
- Adjusted Financial Outlook: Vanda raised its full-year 2026 revenue guidance to $240 million to $290 million, reflecting the potential contribution from NEREUS while maintaining expectations for Fanapt and other products, demonstrating confidence in future growth prospects.
See More
Vanda Pharmaceuticals Q1 2026 Earnings Report
- Disappointing Earnings: Vanda Pharmaceuticals reported a Q1 2026 GAAP EPS of -$0.82, missing expectations by $0.13, indicating challenges in profitability that could undermine investor confidence.
- Slight Revenue Growth: The company achieved revenue of $51.7 million in Q1, a 3.3% year-over-year increase, yet fell short of expectations by $1.2 million, suggesting pressure in market competition and the need for enhanced sales strategies.
- Deteriorating Cash Position: As of March 31, 2026, Vanda's cash and cash equivalents totaled $202.3 million, a decrease of $61.5 million in Q1, which included a one-time $10 million milestone payment to Eli Lilly, reflecting tight cash management.
- Upgraded 2026 Financial Guidance: Vanda raised its total revenue guidance for 2026 to $240 million to $290 million, reflecting contributions from the newly launched NEREUS™ product, while maintaining previous guidance for Fanapt® and other products, demonstrating confidence in the new product's market potential.
See More
Vanda Pharmaceuticals Launches Nereus™ (Tradipitant), the First New Medication for Motion Sickness in Over 40 Years, Now Available in the U.S.
Announcement of New Treatment: Vanda Pharmaceuticals has announced the U.S. commercial availability of Nereus™ (tradipitant), the first new pharmacologic treatment for people suffering from motion sickness in over 40 years.
Significance of the Treatment: This new treatment aims to provide relief for individuals who experience motion sickness, addressing a long-standing need in the pharmaceutical market.
See More
Vanda Pharmaceuticals Launches NEREUS, First New Motion Sickness Drug in 40 Years
- New Drug Launch: Vanda Pharmaceuticals has announced the U.S. commercial launch of NEREUS, marking the first new prescription medicine for motion sickness in over 40 years, expected to meet the needs of approximately 65 to 78 million Americans and significantly improve patient travel experiences.
- Successful Clinical Trials: NEREUS received FDA approval on December 30, 2025, after two pivotal Phase 3 trials demonstrated significant vomiting prevention, enhancing the drug's competitive position in the market.
- Convenient Dosing Regimen: Patients can take one or two capsules about an hour before travel, simplifying the medication process, which is likely to attract more patients and drive sales growth.
- Price Advantage: With a cash-pay price of $85 per dose compared to the standard price of $255, NEREUS offers a significant cost advantage, expected to enhance patient acceptance and market penetration.
See More
